BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZICONIA CERAMIC MOD HEAD

    MDR report key: 6415071 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01653
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 13, 2017
    Report Date
    April 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK915641
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS FOUND UNRELATED DEVIATIONS DURING THE MANUFACTURING PROCESS. ONE UNIT WAS SCRAPPED DURING THE CLEANING PROCESS. NO PRODUCT WAS RETURNED; PRODUCT EVALUATION COULD NOT BE COMPLETED. THIS DEVICE IS USED FOR TREATMENT. FOR BOTH PARTS - COMPLAINT HISTORY REVIEW IDENTIFIED NO OTHER COMPLAINT ON THIS PART AND LOT COMBINATION FOR THIS ISSUE. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 106056 048220 RNWT/BRSTN POR ACET SHL 56MM L NR SZ 24 162253 535770 BI-METRIC PC 12X140MM T1. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 11) ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. ¿WEAR AND/OR DEFORMATION OF ARTICULATION SURFACES.¿ MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 01649.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S HIP WAS REVISED APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO POLY WEAR AND OSYEOLYSIS. THE HEAD AND LINER WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196752 ZICONIA CERAMIC MOD HEAD PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 101710

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R